VALTREX 500 mg FILM-COATED TABLETS

2. What you need to know before taking Valtrex

Do not take Valtrex

• if you are allergic to valaciclovir or aciclovir or any of the other components of this medication (listed in section 6)
• if you have ever developed a widespread skin rash associated with fever, swelling of the lymph nodes, elevated liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

• Do not take Valtrex if the above point applies to you. If you are unsure, talk to your doctor or pharmacist before taking Valtrex.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valtrex if:

• you have kidney problems
• you have liver problems
• you are over 65 years old
• your immune system is weakened.

If you are unsure if any of the above points apply to you, consult your doctor or pharmacist before taking Valtrex.

Be careful with Valtrex – Important Information:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, high body temperature, elevated liver enzymes in blood tests, increased eosinophilia, and swelling of the lymph nodes.

• If you develop a skin rash associated with fever and swelling of the lymph nodes, stop taking valaciclovir and contact your doctor or seek medical attention immediately.

Preventing the spread of genital herpes to others

If you are taking Valtrex to treat or prevent genital herpes, or have had genital herpes in the past, you should practice safe sex, including the use of condoms. This is important to prevent the infection from spreading to others. You should not have sex if you have genital ulcers or blisters.

Other medications and Valtrex

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription or herbal remedies.

Tell your doctor or pharmacist if you are taking any medication that affects the kidneys. These include aminoglycosides, platinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.

Always tell your doctor or pharmacist about other medications you are taking if you are taking Valtrex for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding

Valtrex is not normally recommended for use during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will weigh the benefits for you against the risks for the baby if you take Valtrex while pregnant or breastfeeding.

Driving and using machines

Valtrex may cause side effects that affect your ability to drive.

→ Do not drive or operate machinery unless you are sure it does not affect you.

3. How to take Valtrex

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The dose you should take will depend on why your doctor has prescribed Valtrex for you. Your doctor will tell you the right dosage.

Treatment of shingles

• The usual dose is 1,000 mg (one 1,000 mg tablet or two 500 mg tablets) three times a day.
• You should take Valtrex for seven days.

Treatment of cold sores

• The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours after the first dose (not before 6 hours).
• You should take Valtrex only for one day (two doses).

Treatment of HSV skin infections and genital herpes

• The usual dose is 500 mg (one 500 mg tablet) twice a day.
• For the first infection, you should take Valtrex for five days or up to ten days if your doctor tells you to. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent HSV infections once you have had them

• The usual dose is one 500 mg tablet once a day.
• Some people with frequent recurrences may benefit from taking 250 mg twice a day.
• You should take Valtrex until your doctor tells you to stop treatment.

To prevent CMV infection

• The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) four times a day.
• You should space the doses 6 hours apart.
• Normally, you will start taking Valtrex as soon as possible after surgery.
• You should take Valtrex for about 90 days after surgery, until your doctor tells you to stop treatment.

Your doctor may adjust the dose of Valtrex if:

• you are over 65 years old
• you have a weakened immune system
• you have kidney problems.

• Talk to your doctor before taking Valtrex if any of the above points apply to you.

Taking this medication

• Take this medication orally.
• Swallow the tablets whole with a glass of water.
• Take Valtrex at the same time every day.
• Take Valtrex as instructed by your doctor or pharmacist.

People over 65 years old or with kidney problems

It is very important that while taking Valtrex, you drink water regularlythroughout the day. This will help reduce side effects that can affect the kidneys or nervous system. Your doctor will monitor you for signs of this. Nervous system side effects can include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take more Valtrex than you should

Valtrex is not normally harmful, unless you take too much for several days. If you take too many tablets, you may have nausea, vomiting, kidney problems, or feel confused, agitated, or less alert, see things that do not exist, or lose consciousness. Talk to your doctor or pharmacist if you take too much Valtrex. Bring the package with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valtrex

• If you forget to take Valtrex, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for missed doses.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Symptoms to watch out for

• Stop taking Valtrex and seek medical attention immediately if you notice any of the following symptoms:

Severe allergic reactions(anaphylaxis).These are rare in people taking Valtrex. Rapid development of symptoms including:

• skin rash with redness, itching
• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• drop in blood pressure leading to collapse.

Skin rashes or redness. The adverse skin reaction can appear as rashes with or without blisters. They can cause skin irritation, edema (DRESS syndrome), and fever and flu-like symptoms.

The following side effects can also occur with this medication:

Very common(may affect more than 1 in 10 people):

• headache.

Common(may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhea
• skin reaction after sun exposure (photosensitivity)
• rash
• itching (pruritus).

Uncommon(may affect up to 1 in 100 people):

• feeling confused
• seeing or hearing things that do not exist (hallucinations)
• feeling very sleepy
• tremors
• feeling agitated.

These nervous system side effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valtrex per day. They usually improve when treatment with Valtrex is stopped or the dose is reduced.

Other uncommon side effects:

• difficulty breathing (dyspnea)
• stomach pain
• rash, sometimes with itching, hives (urticaria)
• lower back pain (renal pain)
• blood in urine (hematuria).

Uncommon side effects may appear in your blood tests:

• reduction in the number of white blood cells (leukopenia)
• reduction in the number of plateletsthat help blood clot (thrombocytopenia)
• increase in substances produced by the liver.

Rare(may affect up to 1 in 1,000 people):

• loss of balance and coordination (ataxia)
• slow and slurred speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disturbed thoughts (delirium).

These nervous system side effects usually occur in people with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valtrex per day. They usually improve when treatment with Valtrex is stopped or the dose is reduced.

Other rare side effects:

• kidney problems that cause you to urinate little or not at all.

Frequency not known(cannot be estimated from available data):

• Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS or drug hypersensitivity syndrome, characterized by widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), swelling of the lymph nodes, and possibly other organs. See also section 2.
• Kidney inflammation (tubulointerstitial nephritis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Valtrex

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.
• Store below 30°C.
• Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofValtrex

• The active ingredient is valaciclovir. Each tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride).

The other components are:

Core of the tablet

Microcrystalline cellulose

Crospovidone

Povidone

Magnesium stearate

Anhydrous colloidal silica

Coating

Hypromellose

Titanium dioxide

Macrogol 400

Polysorbate 80

Carnauba wax

Appearance of the product and package contents

Valtrex tablets are presented in aluminum/polyvinyl chloride blisters.

Valtrex 500 mg tablets are available in packs of 10, 30, 42, or 112 film-coated tablets. They are white and marked with “GX CF1” on one side.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer

Glaxo Wellcome, S.A.

Avenida de Extremadura, 3

09400 Aranda de Duero (Burgos)

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Valtrex.

France, Belgium, Italy, Luxembourg, Netherlands: Zelitrex.

Date of last revision of thisleaflet:12/2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.